EP2371406A1 - Spritze - Google Patents

Spritze Download PDF

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Publication number
EP2371406A1
EP2371406A1 EP09830433A EP09830433A EP2371406A1 EP 2371406 A1 EP2371406 A1 EP 2371406A1 EP 09830433 A EP09830433 A EP 09830433A EP 09830433 A EP09830433 A EP 09830433A EP 2371406 A1 EP2371406 A1 EP 2371406A1
Authority
EP
European Patent Office
Prior art keywords
barrel
gasket
silicone oil
syringe
drug
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09830433A
Other languages
English (en)
French (fr)
Other versions
EP2371406A4 (de
Inventor
Kazutoshi HIOKI
Kenji Nohmi
Yoshiaki Miyata
Ippei Matsumoto
Norihiko ASAHI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Taisei Kako Co Ltd
Denka Co Ltd
Original Assignee
Taisei Kako Co Ltd
Denki Kagaku Kogyo KK
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Taisei Kako Co Ltd, Denki Kagaku Kogyo KK filed Critical Taisei Kako Co Ltd
Publication of EP2371406A1 publication Critical patent/EP2371406A1/de
Publication of EP2371406A4 publication Critical patent/EP2371406A4/de
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D7/00—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials
    • B05D7/22—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials to internal surfaces, e.g. of tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/02—Processes for applying liquids or other fluent materials performed by spraying
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B65B3/006—Related operations, e.g. scoring ampoules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3114—Filling or refilling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/3131—Syringe barrels specially adapted for improving sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means

Definitions

  • the present invention relates to a syringe, and more particularly relates to a syringe which is excellent in terms of accuracy of visual inspection of the content and a prefilled syringe filled with a high viscosity drug that are suitable for injection of high viscosity drugs.
  • a prefilled syringe has the tip opening of a barrel sealed with a cap member, is filled with a drug inside the barrel, has the rear end portion of the barrel sealed with a gasket, and is transported and stored in that state.
  • an injection needle or an apparatus for administration is attached to the tip of the barrel, and by pushing a plunger attached to the gasket towards the tip and sliding the gasket inside the barrel, the drug flows out from the injection needle and is administered.
  • prefilled syringes have various advantages, such as allowing drugs to be administered in accurate doses without mistakes even during emergencies as there is no need to prepare the drugs at the point of treatment, being highly sanitary as there is no transferring of drugs, and being easy to operate.
  • prefilled syringes are stored and circulated in a state of being filled with a drug, it may be several years from the filling of the drug in production factories to administration. As such, while it goes without saying that long-term stability is needed, it is also necessary to be able to confirm the safety of the drug by visually inspecting for contamination by impurities. For that reason, the material constituting the barrel needs to be highly transparent, and barrels made of glass, which ensures transparency, have been frequently used in conventional prefilled syringes.
  • a lubricant layer composed of silicone or the like is generally provided on the inner peripheral surface of the barrel and/or the outer peripheral surface of the gasket.
  • silicone in the form of an emulsion
  • a high temperature 200 to 300°C
  • Such contamination by the silicone oil from the inner peripheral surface of the barrel is particularly notable when the viscosity of the drug is high. While the exact mechanism is unclear, this is thought to be due to the high shear stress exerted on the silicone oil adhering to the inner peripheral surface of the barrel when filling the syringe with a drug of high viscosity.
  • silicone oil is not necessarily harmful to the human body, but it is not possible to clearly distinguish between turbidity caused by contamination due to silicone oil and turbidity caused by substantial contamination due to impurities by visual inspection alone, so such syringes may be determined to be defective products during inspection or medical practice and be forced to be discarded without ever being used.
  • the refractive index of the applied silicone oil differs from the refractive index of the drug and the refractive index of the synthetic resin constituting the syringe, resulting in glare on the inner peripheral surface of the barrel, which may interfere with visual inspection or make it seem as if there has been contamination by impurities or a defect such as a scratch on the barrel.
  • the present invention was achieved in view of the above circumstances, with an object of providing a syringe excellent in inspection accuracy while ensuring slidability and sealing properties between the barrel and gasket, and in particular, a syringe that is also suitable for filling with a high viscosity drug.
  • the present inventors found that by spraying a silicone oil of a predetermined kinematic viscosity onto the inner peripheral surface of a resin barrel at a predetermined application amount per unit area, it is possible to suppress separation and contamination by the silicone oil and glare on the inner peripheral surface of the barrel in addition to providing sufficient slidability.
  • the syringe of the present invention is characterized by having a resin barrel, a gasket slidably inserted in the barrel, a plunger attached to the gasket, and a silicone film formed by applying a silicone oil having a kinematic viscosity of 500 to 100,000 cSt to the inner peripheral surface of the above-described barrel in an amount of 5 to 50 ⁇ g per 1 cm 2 of area.
  • a silicone oil having a kinematic viscosity of at least 500 cSt is used as the silicone constituting the silicone film in this syringe, when spraying the silicone oil, the silicone oil is appropriately maintained on the inner peripheral surface of the barrel without running. For that reason, even when a small amount of silicone oil is applied, it is possible to ensure sufficient slidability with the gasket. Additionally, since a silicone oil having a kinematic viscosity of at most 100,000 cSt is used, it can be applied to the inner peripheral surface of the barrel by spraying, and the silicone oil can be evenly applied in the above predetermined application amount per unit area.
  • the occurrence of turbidity due to contamination by the silicone oil can be suppressed, the causes of turbidity in a drug in a prefilled syringe can be limited to cases of contamination by impurities other than silicone oil, and accuracy in visual inspection to ensure safety can be substantially improved. This is particularly applicable to cases where a high viscosity drug which is susceptible to contamination by silicone oil is loaded. Further, when the application amount is within this range, as long as observation is performed by the naked eye, there is also a low likelihood of glare being detected on the inner peripheral surface of the barrel. Moreover, when the amount of the silicone oil applied to the inner peripheral surface of the barrel is at least 5 ⁇ g per 1 cm 2 area, sufficient slidability between the barrel and the gasket can be ensured.
  • the viscosity of a silicone oil having a kinematic viscosity within the above range is high, it is generally not easy to evenly spray the oil. However, even spraying is possible by appropriately adjusting the liquid temperature, air pressure, nozzle diameter and application time etc. In particular, a fine mist can be sprayed to achieve an extremely thin film such as one within the above range by heating the silicone oil within such a range as not to cause denaturation at the time of spraying.
  • the maximum outer diameter of the gasket is designed to be greater than the inner diameter of the barrel such that the difference between the maximum outer diameter of the gasket and the inner diameter of the barrel is at least 0.02 mm and at most 0.50 mm, it is possible to suppress drug leakage from the gap between the gasket and barrel while maintaining the sealing properties of the gasket and ensure sufficient slidability between the barrel and gasket.
  • the glare could be remarkably suppressed when, upon shining an incident beam with a wavelength of 635 nm to 690 nm and a beam width of at most 3.0 mm on a barrel filled with a drug at an optical axis orthogonally intersecting the central axis of the barrel, the angle of refraction from the optical axis of the transmitted light scattered in the same direction as the above-described central axis was within a range of 0.1 to 0.5°.
  • the "angle of refraction" in the present invention refers to the aperture angle from the optical axis of transmitted light scattered along the same direction as the central axis of the barrel of a prefilled syringe filled with a drug when shining an incident beam with an optical axis orthogonally intersecting the central axis of the barrel.
  • the barrel of a prefilled syringe will cause a transmitted beam in a direction perpendicular to the central axis to be highly refracted with the center of curvature as the central axis. Accordingly, refraction occurring in the direction perpendicular to the central axis is affected by solely the shape of the barrel, and cannot indicate small variations in the application state of the silicone oil on the inner peripheral surface of the barrel.
  • the divergence from the optical axis occurring in the same direction as the central axis i.e. the "angle of refraction" in the present invention, is not significantly affected by the shape of the barrel, and can directly reflect the state of application of the silicone oil.
  • a drug can be more stably stored in the barrel and the accuracy of inspection of the content can be substantially improved while ensuring the sealing properties and the slidability between the barrel and gasket.
  • the syringe according the present invention has great utility as a medical apparatus and as a cosmetic apparatus.
  • FIG. 1 is a schematic view of a prefilled syringe which is a preferred embodiment of the present invention.
  • Prefilled syringe 1 can basically adopt the constitution of a conventional prefilled syringe as is, and as shown in Fig. 1 , is constituted by a syringe 10 comprising a barrel 20 with a tip opening 21 at the tip, a liquid-tight, air-tight and slidable gasket 24 in barrel 20, and a plunger 25 attached to the rear end of gasket 24; a cap member 26 for sealing tip opening 21 of barrel 20; and a drug 27 stored inside syringe 10. Moreover, a silicone film 28 formed by spraying a silicone oil is provided on the inner peripheral surface of barrel 20. In Fig.
  • silicone 28 is shown as a film seemingly applied at a fixed thickness, but as long as the amount of silicone oil applied to the inner peripheral surface of barrel 20 is within the range of 5 to 50 ⁇ g per 1 cm 2 area, the desired effects can be sufficiently achieved, so it does not necessarily need to be even.
  • Barrel 20, as shown in Fig. 1 is a cylindrical body provided with tip opening 21 at the tip for the attachment of an injection needle, and a pair of opposing flanges 22 at the rear end for the placement of fingers during drug injection.
  • cap member 26 is attached to tip opening 21 of barrel 20.
  • an injection needle (not shown) instead of cap member 26 may be directly attached.
  • a screw thread portion 23 is provided on the outer peripheral surface of tip opening 21 for attaching cap member 26 or an injection needle.
  • Barrel 20 is formed with a transparent resin material in order to enable visual inspection of the filled drug 27.
  • various resins for example, polystyrenes, polyamides, polycarbonates, polyvinyl chloride, polyvinylidene chloride, poly-(4-methylpentene-1), polyvinyl alcohols, acrylic resins, acrylonitrile-butadiene-styrene copolymer, polyesters such as polyethylene terephthalate, cyclic polyolefins and cyclic olefin copolymers may be mentioned.
  • thermoplastic saturated norbornene resin compositions commercially available under Zeonex (trademark) from the (Japan) Zeon Corporation, particularly those dispersed with a compounding agent such as a gum polymer that is immiscible with the thermoplastic saturated norbornene resin, are preferred. In particular, those having the following properties are most preferred.
  • gasket 24 While there is no particular limitation to the material of gasket 24, in order to maintain air-tightness, it is preferably formed by an elastic body such as rubber or a thermoplastic elastomer. Among them, butyl rubber, which changes little in dimensions upon autoclave sterilization, is particularly preferred as the main ingredient. As the butyl rubber, a halogenated butyl halide that has been chlorinated or brominated in order to improve crosslinkability and adhesiveness etc. may be used. As long as the material is permitted to be used as a medical apparatus or has been conventionally used as a material for forming the gasket of a syringe, there is no particular limitation.
  • the surface material of the gasket from the aspect of cost reduction, for example, materials not surface-treated with a tetrafluoroetilylene resin film or ultra high molecular weight polyethylene film are preferred.
  • a silicone oil may be applied to the surface of the gasket.
  • Gasket 24 preferably has a plurality of ridge portions (ring-shaped convex portions) as shown in Fig. 1 .
  • a plurality of ridge portions and valley portions ring-shaped concave portions
  • drug 27 can be blocked at multiple stages, suppressing leakage of drug 27 from the gap between gasket 24 and barrel 20.
  • the maximum outer diameter of gasket 24 preferably corresponds to the outer diameter of the first ridge portion closest to the tip among the plurality of ridge portions. This is because the first ridge portion closest to the tip among the plurality of ridge portions of gasket 24 is in fact directly in contact with drug 27, so by maximizing the outer diameter of this ridge portion, leakage of drug 27 from the gap between gasket 24 and barrel 20 can be effectively suppressed.
  • the maximum outer diameter of gasket 24 needs to be greater than the inner diameter of barrel 20.
  • the difference between the maximum outer diameter of gasket 24 and the inner diameter of barrel 20 needs to be at least 0.02 mm and at most 0.50 mm. This is because by making the difference between the maximum outer diameter of gasket 24 and the inner diameter of barrel 20 at least 0.02 mm and at most 0.50 mm, leakage of drug 27 from the gap between gasket 24 and barrel 20 can be suppressed while maintaining the sealing properties of gasket 24, and sufficient slidability between barrel 20 and gasket 24 can be ensured.
  • the difference between the maximum outer diameter of gasket 24 and the inner diameter of barrel 20 is preferably at least 0.10 mm, and more preferably at least 0.15 mm. This is because the greater this difference is, the easier it is to suppress drug 27 from leaking from the gap between gasket 24 and barrel 20.
  • the difference between the maximum outer diameter of gasket 24 and the inner diameter of barrel 20 is preferably at most 0.40 mm and more preferably at most 0.35 mm. This is because the smaller this difference is, the better is the slidabillty between the barrel and gasket.
  • the tolerance (variability in dimensional accuracy of the actual product with respect to the designed dimensions) of the maximum outer diameter of gasket 24 after autoclave sterilization is preferably controlled be at most ⁇ 0.10 mm, and is more preferably controlled to be at most ⁇ 0.05 mm. This is because when the variability in dimensional accuracy of gasket 24 is within this range, it is stabilized by the entire syringe 10, and sufficient slidability and sealing properties of the gasket can be ensured.
  • the tolerance (variability in dimensional accuracy of the actual product with respect to the designed dimensions) of the inner diameter of barrel 20 is preferably controlled to be at most ⁇ 0.10 mm, and is more preferably controlled to be at most ⁇ 0.05 mm. This is because when the variability in dimension accuracy of barrel 20 is within this range, it is stabilized by almost the entire syringe 10, and sufficient slidability and sealing properties of the gasket can be ensured.
  • gasket 24 is a structure in which a tetrafluoroethylene resin film or ultra high molecular weight polyethylene film is laminated on the surface of a rubber stopper, keeping the difference between the maximum outer diameter of gasket 24 and the inner diameter of barrel 20 within these ranges might be difficult. This is because when making a gasket 24 with such a complex laminated structure, the production process becomes complicated, and as a consequence thereof, there is a tendency for the disparity in the actual dimensions of gasket 24 with respect to the dimensions of the original design to be greater.
  • gasket 24 is preferably one that is not surface-treated with a resin film. This is because the structure of the gasket itself can be designed into a simple shape, and the production process of the gasket itself can be simplified by doing so. That is, in syringe 10 of the present embodiment, the highly accurate maximum outer diameter of gasket 24 is preferably controlled by improving the dimensional accuracy in the production process for both gasket 24 and barrel 20 or strictly applying the inspection process for dimensional accuracy in addition to using gasket 24 that is not surface-treated with a resin film.
  • plunger 25 only needs to be equipped with a strength that can withstand the bending and pressing force required to make gasket 24 slide inside barrel 20, and may be made of, for example, a hard plastic material such as polyethylene or polypropylene, but as long as the material is permitted to be used as a medical apparatus or has been conventionally used as a material for forming the gasket of a syringe, there is no particular limitation.
  • a hard plastic material such as polyethylene or polypropylene
  • Cap member 26 tightly adheres to tip opening 21 of barrel 20, air-tight seals tip opening 21, and may be made using an elastic body or hard resin such as butyl rubber, high-density polyethylene, polypropylene, polystyrene, or polystyrene terephthalate, but as long as the material is permitted to be used as a medical apparatus or has been conventionally used as a material for forming the gasket of a syringe, there is no particular limitation.
  • a female thread portion for threading thread portion 23 formed on the outer peripheral surface of tip opening 21 of barrel 20 is formed on the inner peripheral surface of cap member 26.
  • Silicone film 28 formed by spraying a silicone oil having a predetermined kinematic viscosity as described below is provided on the inner peripheral surface of barrel 20. Since the silicone oil applied to barrel 20 only needs to satisfy the predetermined application amount per unit area, the thickness of silicone film 28 does not necessarily need to be even across the entirety of barrel 20.
  • silicone oil forming silicone film 28 applied to the inner peripheral surface of the barrel is basically polydimethylsiloxane
  • a polydimethylsiloxane with a side chain or terminal substitution within a range not impairing lubricity may be used.
  • polymethylphenylsiloxane and polymethylhydrogen siloxane may be mentioned.
  • Various additives may be added to the silicone oil as necessary.
  • the above-described silicone oil preferably has a kinematic viscosity of 500 to 100,000 cSt at 25 °C, and in particular, one having a kinematic viscosity of 1,000 to 30,000 cSt is more preferably used.
  • the kinematic viscosity is at least 500 cSt, the silicone oil is appropriately maintained at the spraying site on the inner peripheral surface of barrel 20 without running from the inner peripheral surface of barrel 20, so the slidability between barrel 20 and gasket 24 can be sufficiently ensured with a small amount of application.
  • the kinematic viscosity is at most 100,000 cSt, application to the inner peripheral surface of barrel 20 by spraying is possible.
  • the application amount of the silicone oil constituting silicone film 28 is preferably 5 to 50 ⁇ g, and particularly preferably 10 to 30 ⁇ g, per 1 cm 2 of the inner peripheral surface of barrel 20. If the application amount of the silicone oil is at least 5 ⁇ g per 1 cm 2 of the inner peripheral surface of the barrel, a sufficient slidability between barrel 20 and gasket 24 can be ensured. Moreover, if the application amount is at most 50 ⁇ g per 1 cm 2 of the inner peripheral surface of the barrel, even if the silicone oil is mixed into the drug when loading drug 27, the amount of contamination can be kept extremely small. Further, as long as observation is performed by the naked eye, glare will not be detected on the inner peripheral surface of barrel 20.
  • Silicone film 28 is formed by evenly spraying a silicone oil having the above-described kinematic viscosity on the inner peripheral surface of barrel 20 using a spray system compatible with high viscosity solutions. Since the silicone oil applied in the present invention has a high kinematic viscosity, liquid temperature, air pressure, nozzle diameter and application etc. need to be appropriately adjusted in order to be able to evenly spray the silicone oil on the inner peripheral surface of barrel 20. Particularly, in the case of the above silicone oil of a high kinematic viscosity heating the silicone oil when spraying in particular makes the silicone oil easier to spray.
  • a silicone oil having a kinematic viscosity of 500 to 100,000 cSt at 25 °C is preferably used, and in particular, one with a kinematic viscosity of 1,000 to 50,000 cSt is more preferably used.
  • the kinematic viscosity is at least 500 cSt, the applied silicone oil does not run and the lubricating action is maintained for a long period of time.
  • the kinematic viscosity is at most 100,000 cSt, even application over the entire surface of the gasket is possible.
  • a conventionally used method can be used, for example, a method in which the silicone oil is directly added to a tank containing the gasket and mixed or a method in which the gasket is mixed in water suspended with the silicone oil may be used.
  • the application amount of the silicone oil is preferably at most 0.3 mg and is more preferably at most 0.15 mg per 1 cm 2 of the surface area of the gasket
  • syringe 10 of the above constitution is particularly suitable for loading a high viscosity drug.
  • a high viscosity drug is loaded, a high shear force is exerted on the inner peripheral surface of the barrel, so the silicone oil applied to the inner peripheral surface of the barrel is easily mixed into the drug, and as a result thereof, turbidity occurs easily.
  • a silicone oil of the above predetermined viscosity is applied to the inner peripheral surface of the barrel at the above predetermined application amount per unit area, the amount of contamination by the silicone oil can be kept extremely small. For that reason, syringe 10 of the above constitution can be considered to be particularly suitable for high viscosity drugs in which turbidity occurs easily.
  • syringe 10 of the above constitution can be considered to be particularly suitable for high viscosity drugs that tend to lead to higher maximum values of the extrusion pressure during sliding.
  • syringe 10 of the above constitution allows stable storage of a high viscosity drug, even with a viscosity of approximately 60,000 mPa ⁇ s, and as such a drug, an aqueous solution of 1% high molecular weight sodium hyaluronate with a weight average molecular weight of 600,000 to 3,700,000 may be mentioned in particular.
  • Fig. 2 is a schematic view showing an embodiment of a device for measuring an angle of refraction.
  • This angle of refraction measuring device uses a laser oscillator 31 for shining a light beam (incident beam 33) on a prefilled syringe 1 and a projection plate 32 for projection of a light beam (transmitted beam 34) leaving prefilled syringe 1.
  • Laser oscillator 31 is a device for shining incident beam 33 of an optical axis 41 orthogonally intersecting the central axis 40 of barrel 20 onto prefilled syringe 1 filled with a drug.
  • the wavelength of the oscillating laser is not particularly limited, and while a visible laser of any of red, green, blue and purple etc. may be used, the value of the angle of refraction changes with the wavelength, so the measurement needs to be carried out at a predetermined wavelength. As such, one within a wavelength range of 635 to 690 nm, which is that of common red lasers, is preferably used.
  • Projection plate 32 is not particularly limited as long as it is an opaque flat plate without any distortion on the surface. Projection plate 32 is arranged such that it is perpendicular to optical axis 41 of the light beam shone from laser oscillator 31.
  • the position of laser oscillator 31 is first fixed, then projection plate 32 is fixed such that it is perpendicular to the optical axis 41 of the light beam shone from laser oscillator 31.
  • this state i.e. a state in which the object of measurement, prefilled syringe 1, is not positioned, the light beam shone from laser oscillator 31 is projected onto projection plate 32.
  • the diameter of the projection image 42 shall be considered to be the beam width "A" of incident beam 33.
  • the direction of the laser oscillator is adjusted such that the direction of the short axis of the oval matches with the direction of the central axis of the barrel.
  • the length of the short axis of the oval shall be considered to be the beam width "A" of incident beam 33.
  • laser oscillators making projection image 42 a shape other than round or oval are not suitable for measuring the angle of refraction in the present invention. Since it is more difficult to detect the difference in angle of refraction when the beam width "A" of incident beam 33 is large, it is preferably at most 3.0 mm and more preferably at most 2.0 mm.
  • prefilled syringe 1 is placed at a predetermined position on optical axis 41.
  • the position of prefilled syringe 1 is adjusted such that the central axis 40 of prefilled syringe 1 orthogonally intersects optical axis 41.
  • laser oscillator 31 shines a light beam (incident beam 33) on prefilled syringe 1, and transmitted beam 34 leaving prefilled syringe 1 is projected onto projection plate 32.
  • the width "D" in the same direction as central axis 40 of projection image 42 projected on projection plate 32 and the distance "L" from central axis 40 of prefilled syringe 1 to projection plate 32 are measured.
  • the angle of refraction is an aperture angle " ⁇ " from optical axis 41 of transmitted beam 34 scattered in the same direction as central axis 40 when shining incident beam 33 of optical axis 41 orthogonally intersecting central axis 40 of barrel 20 onto prefilled syringe 1 filled with a drug. Consequently, the angle of refraction can be obtained by the following formula using beam width "A" of incident beam 33 shone from laser oscillator 31, distance "L” from central axis 40 of prefilled syringe 1 to projection plate 32 and width "D" in the same direction as central axis 40 of projection image 42 of transmitted beam 34 projected on projection plate 32.
  • Angle of Refraction ⁇ tan - 1 ⁇ D - A / 2 ⁇ L
  • the entire barrel 20 took the form of a single compartment filled with a drug, but the inside of barrel 20 may be separated into multiple compartments using at least one sealing stopper to achieve the form of a multi-compartment syringe. In that case, drug contamination and leakage can be more certainly prevented, and multiple drugs can be loaded into a single syringe.
  • a silicone oil of a kinematic viscosity of 5,000 cSt (“KF-96-5000cs" manufactured by Shin-Etsu Chemical Co., Ltd.) was sprayed under the following conditions such that the average application amount was 18 ⁇ g within a range of 12 to 25 ⁇ g per 1 cm 2 .
  • a thermoplastic saturated norbornene resin composition commercially available as Zeonex (trademark) from the (Japan) Zeon Corporation was used as the COP resin. (Silicone oil spraying conditions) Spraying time: 0.05 second Air pressure: 0.5 MPa Silicone oil heating temperature: 180 °C Nozzle diameter: 1.0 mm
  • Example 1 a barrel similar to that of Example 1 (Comparative Example 1) was prepared, and compared with the barrel of the above Example 1 for light transmittance. The following device and method were used to measure light transmittance.
  • Example 1 Sample Measurement Measured Value Average Example 1 (with silicone oil application) 1 st 0.008 0.006 2 nd 0.006 3 rd 0.005 Comparative Example 1 (without silicone oil application) 1 st 0.007 0.007 2 nd 0.009 3 rd 0.006
  • Example 1 As shown in the above Table 1, even when a silicone film was formed under the conditions described in Example 1, the absorptance did not appear to change substantially as compared to the case where silicone oil was not applied. Accordingly, the silicone film formed under the conditions of Example 1 was confirmed to not affect the efficiency of visual inspection.
  • Example 2 a barrel on which a silicone film was formed was prepared in the same manner as Example 1, and a prefilled syringe was assembled using this barrel in the same manner as Example 2.
  • Example 2 a barrel on which a silicone film was formed was prepared in the same manner as Example 1, and a prefilled syringe was assembled using this barrel in the same manner as Example 2.
  • a silicone oil was further applied to the surface of the gasket at 0.1 mg per 1 cm 2 of the surface. Specifically, a silicone oil with a kinematic viscosity of 5,000 cSt was added to a tank filled with water in an amount that would achieve 0.13 mg per 1 cm 2 with respect to the total surface area of the entire gasket, and mixed for 10 minutes to disperse it. A gasket was put into the tank, and after mixing for 10 minutes at 100°C while blowing a vapor from the bottom, the water was drained, rinsing was performed and autoclave sterilization was carried out. The application amount of the silicone oil was confirmed by gravimetry, and verified to be 0.10 mg per 1 cm 2 of the gasket surface. Other than using this gasket, a prefilled syringe was assembled in the same manner as Example 2.
  • a silicone oil was further applied to the surface of the gasket at 0.2 mg per 1 cm 2 of the surface. While the application method was the same as Example 5, the silicone oil was added in an amount that would achieve 0.26 mg per 1 cm 2 with respect to the total surface area of the entire gasket. The application amount of the silicone oil was confirmed in the same manner as Example 5, and was 0.20 mg per 1 cm 2 of the gasket surface. Other than using this gasket, a prefilled syringe was assembled in the same manner as Example 2.
  • Example 2 a barrel on which a silicone film was formed was prepared in the same manner as Example 1, and a prefilled syringe was assembled using this barrel in the same manner as Example 2.
  • a mixed silicone oil with a kinematic viscosity of 150,000 cSt prepared by mixing 370 g of a silicone oil with a kinematic viscosity of 300,000 cSt ("KF-96-300000cs" manufactured by Shin-Etsu Chemical Co., Ltd.) and 630 g of a silicone oil with a kinematic viscosity of 100,000 cSt ("KF-96-100000cs" manufactured by Shin-Etsu Chemical Co., Ltd.)
  • a barrel on which a silicone film was formed was prepared in the same manner as Example 1, and a prefilled syringe was assembled using this barrel in the same manner as Example 2.
  • Example 2 Other than spraying a silicone oil to form a silicone film with an average application amount of 100 ⁇ g per 1 cm 2 , a barrel on which a silicone film was formed was prepared in the same manner as Example 1, and a prefilled syringe was assembled using this barrel in the same manner as Example 2.
  • a silicone oil was further applied to the surface of the gasket at 0.4 mg per 1 cm 2 of the surface. While the application method is the same as Example 5, the silicone oil was added in an amount that would achieve 0.52 mg per 1 cm 2 with respect to the total surface area of the entire gasket. The application amount of the silicone oil was confirmed in the same manner as Example 5, and was 0.41 mg per 1 cm 2 of the gasket surface. Other than using this gasket, a prefilled syringe was assembled in the same manner as Example 2.
  • the prefilled syringes prepared in the above Examples 2 to 6 and Comparative Examples 2 to 5 were evaluated by the following methods for intermixture of silicone oil into the drug, glare on the inner peripheral surface of the barrel and sliding resistance.
  • Injection needles (23G x 1 1 ⁇ 4; manufactured by Terumo Corporation) were affixed to the tip of the prefilled injection needles, and initial pressure and extrusion pressure when discharging the drugs at an extrusion speed of 100 mm/min. were measured using a testing machine ("EZ-TEST" manufactured by Shimadzu Corporation). Additionally, for the initial pressure measurement, samples stored for a month at 40 °C after production were used. The results are shown in Table 2.
  • the prefilled syringes on which a silicone film was formed satisfying the predetermined conditions according to the invention were observed to have no silicone oil contaminating the drugs and no glare on the inner peripheral surface of the barrels, and they exhibited excellent properties in terms of slidability.
  • the silicone oil was also applied at the predetermined amount to the surface of the gaskets, the initial pressure could be suppressed so much that a local maximum was not observed.
  • a silicone oil of a kinematic viscosity of 5,000 cSt (“KF-96" manufactured by Shin-Etsu Chemical Co., Ltd.) was sprayed under the following conditions to form a silicone film where the average application amount was 18 ⁇ g per 1 cm 2 .
  • thermoplastic saturated norbornene resin composition commercially available as Zeonex (trademark) from the (Japan) Zeon Corporation was used as the COP resin. Additionally, during the production and inspection of the barrel, the tolerance control of the inner diameter ( ⁇ 0.05 mm) was particularly strictly observed. (Silicone oil spraying conditions) Spraying time: 0.05 second Air pressure: 0.5 MPa Silicone oil heating temperature: 180 °C Nozzle diameter: 1.0 mm
  • a gasket made of butyl rubber a kind of rubber material whose surface is not resin treated, was produced and inspected by controlling the tolerance of the outer diameter 0 to 12.70 ⁇ 0.10 mm (first ridge portion), ⁇ to 12.0 ⁇ 0.10 mm (valley portion) and full length to 10.0 ⁇ 0.30 mm. Additionally, since a butyl rubber was used for this gasket, the dimensional changes due to autoclave sterilization were small as compared to general gaskets, and even when sterilized, would be kept within a tolerance range of ⁇ 0.10 mm. Additionally, the gasket was applied with the silicone oil (KF-96-5000cs manufactured by Shin-Etsu Chemical Co., Ltd.) at 0.1 mg per 1 cm 2 area.
  • silicone oil KF-96-5000cs manufactured by Shin-Etsu Chemical Co., Ltd.
  • a syringe was prepared in basically the same manner as Example 7 but differed in that a gasket of butyl rubber whose surface was laminated with a tetrafluoroethylene resin film, having a tolerance of an outer diameter ⁇ of 12.70 ⁇ 0.10 mm (first ridge portion), ⁇ of 12.0 ⁇ 0.10 mm (valley portion) and full length of 10.0 ⁇ 0.30 mm was used and silicone oil was not applied.
  • Example 7 and Comparative Example 6 were preliminarily checked for how the dimensions of the gaskets before autoclaving would change after autoclaving.
  • a syringe was prepared in basically the same manner as Example 7 but differed in that a 5 ml volume barrel formed with a COP resin as the main ingredient, and produced and inspected by controlling the tolerance of the outer diameter to 15.05 ⁇ 0.1 mm, the inner diameter to 12.45 ⁇ 0.20 mm, the full length to 79.0 ⁇ 0.2 mm and the flange diameter ⁇ to 22.0 ⁇ 0.2 mm was used.
  • Example 7 Since the most lenient combined tolerances in Example 7 for the barrel inner diameter ⁇ is 12.50 mm and for the first ridge portion of the gasket ⁇ is 12.60 mm, the difference between them is 0.10 mm. Even in that case, when real liquid leakage tests were performed as described below, the ability to secure air-tightness was confirmed. On the other hand, since the tightest combined tolerances in Example 7 for the barrel inner diameter ⁇ is 12.40 mm and for the first ridge portion of the gasket ⁇ is 12.80 mm, the difference between them is 0.40 mm. Even in that case, a good slidability was confirmed (data not shown).
  • injection needles 23 G x 1 1 ⁇ 4; manufactured by Terumo Corporation
  • plungers were affixed thereto
  • the extrusion pressures when compressing the plungers at a speed of 100 mm/min. were measured using an extrusion tester (EZ-TEST manufactured by Shimadzu Corporation).
  • Table 3 shows the results of measurements of the initial pressure (extrusion pressure at a peak appearing within 5 mm from the start of compression) in ten syringes of each sample in a state not filled with drug solutions.
  • Table 4 shows the results of measuring the maximum pressure (maximum value of the extrusion pressure) in 10 syringes of each sample filled with drug solutions.
  • Example 7 when comparing Example 7 and Comparative Example 7 in Table 3, it is clear that the control of gasket tolerances greatly improved the initial pressure (locking). Additionally, from Table 4, it is clear that the control of gasket tolerances also improved the maximum pressure.
  • Example 7 After filling the syringes of Example 7 and Comparative Example 7 with solutions of different viscosities and storing them at 40 °C for one month, slidability was measured and compared (same gaskets). The test results are shown in Table 5.
  • he inner peripheral surface of a 5 ml volume barrel that was formed with a COP resin as the main ingredient had a cylindrical outer diameter of 15.05 mm, a cylindrical inner diameter of 12.45 mm and a full length of 79.0 mm, was sprayed with a silicone oil of a kinematic viscosity of 5,000 cSt ("KF-96-5000cs" manufactured by Shin-Etsu Chemical Co., Ltd.) under the following conditions to be within a range of 0 to 150 ⁇ g per 1 cm 2 .
  • a thermoplastic saturated norbornene resin composition commercially available as Zeonex (trademark) from the (Japan) Zeon Corporation was used as the COP resin.
  • Glare evaluation criteria The presence of glare on the inner peripheral surface of the barrel of each prefilled syringe was visually evaluated by a group of five panelists consisting of skilled quality inspectors. Glare evaluation criteria:

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AU2009323307B2 (en) 2015-02-19

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